FDA Device recall Z-0009-2020
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators
- FDA Device
- Class I
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class I recall of Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators by Teleflex Morrisville, citing device vented gas below the stated pressure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0009-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-06-14 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Teleflex Morrisville |
| Distribution | US |
Product
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Reason
Device vented gas below the stated pressure.
Identifiers
| code_info | Catalog # 2691 SKU #: XTF0046 Lot #'s: 180806, 180910, 181029, 181105, 181204, 190225 and 190327 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0009-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.